Status:
COMPLETED
Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics
Lead Sponsor:
Denver Health and Hospital Authority
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Alcohol Related Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study objective was to determine whether liver injury develops in alcoholic patients who ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from two community d...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Any patient, regardless of gender or ethnicity, who was:
- 18 years or older
- admitted to one of the two controlled access alcohol detoxification centers with a positive BAL at the time of admittance
- signed a written informed consent form.
- Patients were excluded from the study at baseline if any of the following were present:
- serum acetaminophen level greater than 20 mcg/ml
- serum AST or ALT levels greater than 200 IU/L
- INR greater than 1.5
- if female, positive for beta-subunit of chorionic gonadotropin
- clinically intoxicated, psychiatrically impaired or unable to give informed consent
- known hypersensitivity to acetaminophen
- history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment
- currently enrolled in another trial or had been enrolled in another trial in the preceding three months.
Exclusion
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2004
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00402571
Start Date
January 1 2002
End Date
July 1 2004
Last Update
February 9 2009
Active Locations (2)
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1
Denver CARES
Denver, Colorado, United States, 80204
2
Recovery Centers of King County
Seattle, Washington, United States, 98122